Of major concern in the care of wounds such as incurred in joint surgery are relief of post-operative pain, avoidance of infection, hastening of healing and early joint motion, and decrease in the length of the patient hospital stay. Traditional post-operative management of orthopaedic wounds or traumatic wounds have varied in approach whereby wounds are left open or closed, with or without drains to drain out the debris and blood. Debris and blood are an excellent culture medium which is easily contaminated in dependence upon the wound environment. Accumulation of fluid in the wound causes swelling, pain and delayed healing.
Treatment of pain relief by means of narcotics has drawbacks such as constipation, drowsiness, stasis pneumonitis, itching, vomiting, confusion and ataxia. Problems associated with epidural analgesia include itching, constipation, increased blood loss, severe ataxia and very expensive multiple injections. Thus, the need has existed for new and improved means for management of pain relief and maintenance of a sterile environment.
U.S. Pat. No. 5,616,121, issued to McKay on Apr. 1, 1997, discloses a treatment for alleviating pain in joint wounds through use of irrigation with a medicinal solution. Irrigation lessens the risk of infection and scar tissue that would otherwise occur from accumulated debris and fluid. The patented treatment provides an infusion tubing for infusing a prepared solution into the wound, and a suction tubing for suctioning fluids from the wound. The infusion tubing and suction tubing are joined to communicate with a single tube that is inserted in the wound. Through the use of valves and controlled pump operation, successive timed intervals of infusion and suction, separated by interruption intervals, bathing of the wound is achieved.
Important criteria for use of medical devices in post operative care management are the following. The risk to the health or well being of the patient should be insignificant. Any device that is connected internally to the patient to infuse or subtract fluid should be a closed, sterile system to prevent invasion of environmental contaminants. As patients should be ambulatory as early as possible to prevent deep vein thrombosis, the device should be portable, thereby permitting patient mobility. Mobility also enhances the prospects of early rehabilitation and shortened hospital stay.
While the above described McKay patent meets these criteria, it has been found through the present invention that significant additional improvement is obtainable. The use of separate infusion tubes and suction tubes in the patented method avoids the mixing of the infusion solution and the joint fluids in either of the tubes. The separation of infusion periods and suction periods by interrupted intervals, minimizes such mixing in the single insertion tube. The single insertion tube, however, does have the disadvantage that debris or bacteria remaining therein from a previous suction period may be readministered to the joint during the following infusion period. A further disadvantage is that the pressure in the joint is subject to relatively wide variation over the repeated processes of infusion, interruption and suction. Negative pressure is to be avoided as bacteria can be drawn into the wound along the drain and through the skin.
A desirable practice during surgery and its immediate aftermath is to collect patient blood loss for reinfusion into the body if necessary. Reinfusion of the patient's blood is a preferable alternative to transfusion of blood from an unknown donor. Apparatus for autotransfusion are disclosed, for example, in U.S. Pat. No. 4,443,220, issued to Hauer et al. on Apr. 17, 1984, and in U.S. Pat. No. 5,279,550, issued to Habib et al. on Jan. 18, 1994. For post-operative treatment of joint wounds, patient bleeding occurring during an initial period would be collected, to be followed by an extended period of irrigation treatment, such as the McKay patent approach, or other care management. The entire procedure would involve set up and application of a blood collection device exemplified by the above identified patents, removal of this device, and subsequent application of the McKay patent irrigation system. This procedure has the disadvantages of subjecting the patient to added discomfort in the exchange of medical devices, increased time required to administer the exchange while maintaining a sterile environment, and the expense of the two medical devices necessary to perform both functions.
The need therefore exists for a single medical device, such as that of the McKay patent, that can perform both a blood saving function and a wound irrigation function. Such an apparatus should assure that the collection and saving of blood is accomplished without damage to blood cells.